Retrospective Cohort Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Nov 15, 2019; 11(11): 1031-1042
Published online Nov 15, 2019. doi: 10.4251/wjgo.v11.i11.1031
Revisiting oral fluoropyrimidine with cetuximab in metastatic colorectal cancer: Real-world data in Chinese population
Ka-On Lam, Man-Chi Fu, Kin-Sang Lau, Kam-Mo Lam, Cheuk-Wai Choi, Wan-Hang Chiu, Cheng-Man Yuen, Lai-Han Kwok, Fong-Kit Tam, Wing-Lok Chan, Sum-Yin Chan, Pui-Ying Ho, To-Wai Leung, Ho-Fun Lee
Ka-On Lam, Man-Chi Fu, Cheuk-Wai Choi, Wing-Lok Chan, Ho-Fun Lee, Department of Clinical Oncology, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China
Ka-On Lam, Kin-Sang Lau, Wing-Lok Chan, Sum-Yin Chan, Pui-Ying Ho, To-Wai Leung, Ho-Fun Lee, Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, China
Ka-On Lam, Ho-Fun Lee, Clinical Oncology Centre, The University of Hong Kong- Shenzhen Hospital, Shenzhen 518053, Guangdong Province, China
Kam-Mo Lam, Cheng-Man Yuen, Lai-Han Kwok, Fong-Kit Tam, Department of Pharmacy, Queen Mary Hospital, Hong Kong, China
Wan-Hang Chiu, Department of Diagnostic Radiology, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China
Author contributions: Lam KO, Fu MC, Lau KS, Lau KM, and Leung TW designed the study; Lam KO, Lau KS, Lam KM, Choi CW, Chiu WH, Yuen CM, Kwok LH, Tam FK, Chan WL, Chan SY, and Ho PY acquire and analysed the data; Lam KO, Fu MC, Lau KS, Choi CW, Chiu WH,Leung TW, and Lee HF interpreted the data; all authors were involved in drafting the article and making critical revisions and final approval of the version of the article to be published.
Institutional review board statement: This study was approved by the institutional review board (HKU/HA HKW IRB UW 15-315).
Informed consent statement: Informed consent was waived by the institutional review board because this is a retrospective study.
Conflict-of-interest statement: Lam KO received research grants from Bayer, Roche, and Taiho, and was on advisory boards/received honorarium from Amgen, Bayer, BMS, Eli Lilly, Merck, MSD, Roche, Sanofi-Aventis, and Taiho. All other authors declare no conflict of interest.
STROBE statement: The authors have read the STROBE statement-checklist of items, and the manuscript was prepared and revised according to the STROBE statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Ka-on Lam, MBBS, Clinical Assistant Professor, Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 1/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, China. lamkaon@hku.hk
Telephone: +852-22554352 Fax: +852-28726426
Received: June 4, 2019
Peer-review started: June 6, 2019
First decision: August 23, 2019
Revised: September 7, 2019
Accepted: September 13, 2019
Article in press: September 13, 2019
Published online: November 15, 2019
Abstract
BACKGROUND

Cetuximab in combination with oral fluoropyrimidine (FP) remains controversial in metastatic colorectal cancer (mCRC). In view of the regional variation in the tolerability of FP, we conducted a retrospective analysis to compare oral FP with infusional FP in combination with cetuximab in Chinese population.

AIM

To compare the efficacy and safety profile of cetuximab in combination with oral FP and infusional FP in Chinese population in the real-world setting.

METHODS

A retrospective cohort study was done to analyse consecutive patients with Kras wild-type mCRC who received first-line treatment with cetuximab and FP-based chemotherapy in our unit from January 2010 to December 2015. Ninety-five eligible patients were included. The median follow-up of our cohort was 65.0 mo.

RESULTS

The median progression-free survival (mPFS) and median overall survival (mOS) of the entire cohort were 9.66 mo (95%CI: 7.72–12.5) and 25.8 mo (95%CI: 18.7–35.6), respectively. Between oral FP and infusional FP, there was no statistical significant difference in the mPFS [9.79 mo (95%CI: 7.49–12.7) vs 9.63 mo (95%CI: 6.34–13.4); P = 0.72] and mOS [25.8 mo (95%CI: 15.2–35.6) vs 26.3 mo (95%CI: 18.7–41.2); P = 0.63]. Grade 3 or above adverse events were reported in 28.4% of patients, being similar with oral and infusional FP, and included 10.5% of neutropenia and 2.1% of diarrhoea events.

CONCLUSION

The current analysis demonstrates comparable efficacy and safety profiles of cetuximab in combination with oral and infusional FP in Chinese population. The results expand treatment options for Chinese patients and invite revision of existing treatment guidelines to incorporate oral FP-based chemotherapy plus cetuximab.

Keywords: Capecitabine, 5-Fluorouracil, Cetuximab, Metastatic colorectal cancer, Chinese

Core tip: Cetuximab in combination with oral fluoropyrimidine (FP) remains controversial in metastatic colorectal cancer. A retrospective cohort analysis was performed to compare oral FP with infusional FP in combination with cetuximab in Chinese population in the real-world setting. Our analysis demonstrated comparable efficacy and safety profiles of cetuximab in combination with oral and infusional FP. Thus, oral FP-based chemotherapy should be considered as a valid option in Chinese patients receiving cetuximab.